Ambulatory Surgical ProceduresSACHSNCT02037009
Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study
A study testing Health care organization (anesthetic surveillance) in people with Ambulatory Surgical Procedures and Ocular Anterior Segment Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
In France, cataract surgery is the most frequent surgical procedure, performed with local anesthesia and most often very light techniques using eye-drops. Technical improvements of surgical and anesthesic procedures have led many countries to implement alternative surveillance procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ambulatory Surgical Procedures, Ocular Anterior Segment Surgery
- What is being tested?
- Health care organization (anesthetic surveillance)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient scheduled for ocular anterior segment surgery (cataract, glaucoma, pterygium) with local or topic anesthesia
Who cannot join
- patient refusing to participate in the study or without health insurance
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
In France, cataract surgery is the most frequent surgical procedure, performed with local anesthesia and most often very light techniques using eye-drops. Technical improvements of surgical and anesthesic procedures have led many countries to implement alternative surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic surveillance (doctors or nurses) should be qualified in anesthesia.
In this study, the investigators aim to assess the feasibility and safety of a centralised monitoring station outside of the operating rooms, as an alternative to the presence of 1 anesthetic nurse in each operating room.
Read the detailed description
In their hospital, the investigators will study the following alternatives for the anesthetic surveillance of the 3 operating rooms where surgery of the ocular anterior segment is performed: 1) the usual procedure, with the presence of 3 anesthetic nurses (1 in each operating room) and 2) a new organization with an anesthetic nurse checking a centralised monitoring station and a back-up anesthetic nurse ready to intervene inside the 3 operating rooms whenever needed.
The 2 procedures will be successively implemented during 3 to 4 sequences, until the number of surgical procedures statistically required have been studied.
The investigators aim to demonstrate that the centralised monitored surveillance does not put the patients at risk more often than the current surveillance procedure.
- Being tested
- Health care organization (anesthetic surveillance)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health care organization (anesthetic surveillance)Other
| Study group | Role | What they receive |
|---|---|---|
| Usual surveillance | No intervention | surveillance performed by a qualified nurse, present in the operating room during the whole anesthesia. |
| centralised monitoring surveillance | Experimental | 1 anesthetic nurse is posted at a centralised monitoring station outside of the 3 operating rooms, while another one can intervene inside the 3 operating rooms whenever needed. Interphones allow communication between the monitoring station and the operating rooms. Receives: Other: Health care organization (anesthetic surveillance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic potential impact on surgery conditions
Incidence rate of at least 1 of the following events, during surgery:
- blood pressure > 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes)
- cardiac frequency < 45/min for at least 1 mn
- SaO2 <85% for at least 1 mn
- poor operating conditions (rated ≤ 7 by the surgeon, on a numeric scale from 0 to 10=excellent conditions). Assessment at the exit of operating room.
Measured: during surgical procedure
Secondary outcomes (8)
interventions of the back-up anesthetic nurse
mean number of interventions of the back-up anesthetic nurse during the procedures proportion of surgical procedures requiring at least one intervention of the nurse
Measured: during surgical procedure
patient pre-surgical stress
auto-assessment of stress level using a 0 to 10 (maximum stress) scale
Measured: baseline
pain during surgical procedure
retrospective auto-assessment of patient pain using a 0 to 10 (maximum pain) scale
Measured: within 10 minutes after surgery
patient satisfaction
auto-assessment of patient satisfaction using a 0 to 10 (fully satisfied) scale
Measured: within 10 minutes after surgery
incidence rate of each of the events included in the primary outcome
incidence rate of blood pressure > 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes) incidence rate of cardiac frequency < 45/min for at least 1 mn incidence rate of SaO2 <85% for at least 1 mn incidence rate of poor operating conditions (rated < 7 by the surgeon, on a numeric scale from 0 to 10 (excellent conditions)
Measured: during surgical procedure
patient agitation
assessed by the surgeon using a 0 to 10 (very agitated) scale
Measured: within 10 minutes after surgery
operating conditions
auto-assessment by the surgeon of the operating conditions, on a 0 to 10 (excellent conditions) scale and on a 0 to 10 (completely safe) scale
Measured: within 10 minutes after surgery
working conditions
auto-assessment of working conditions by the anesthetic nurses, on a 0 to 10 (excellent) scale and on a 0 to 10 (completely safe) scale
Measured: at the end of a working day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ambulatory Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean-Michel DEVYS, MD, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037009
- Sponsor's protocol ID
- SC_JMD_2013-1
- Acronym
- SACHS
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2014
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clariot S, Moures JM, Lopes L, Gatinel D, Gabison E, Nicolaos G, Salomon L, Devys JM. Centralized monitored anesthesia care by nurse anesthetist for cataract and glaucoma surgery in a 1:3 ratio: a non-inferiority study. Minerva Anestesiol. 2025 Mar;91(3):176-183. doi: 10.23736/S0375-9393.24.18455-6. Epub 2024 Dec 4.
PubMed 39630143
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study
- ClinicalTrials.gov ID
- NCT02037009
- Acronym / sponsor ID
- SACHS / SC_JMD_2013-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Ministry of Health, France
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In France, cataract surgery is the most frequent surgical procedure, performed with local anesthesia and most often very light techniques using eye-drops. Technical improvements of surgical and anesthesic procedures have led many countries to implement alternative surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic surveillance (doctors or nurses) should be qualified in anesthesia.
In this study, the investigators aim to assess the feasibility and safety of a centralised monitoring station outside of the operating rooms, as an alternative to the presence of 1 anesthetic nurse in each operating room.
Detailed description
In their hospital, the investigators will study the following alternatives for the anesthetic surveillance of the 3 operating rooms where surgery of the ocular anterior segment is performed: 1) the usual procedure, with the presence of 3 anesthetic nurses (1 in each operating room) and 2) a new organization with an anesthetic nurse checking a centralised monitoring station and a back-up anesthetic nurse ready to intervene inside the 3 operating rooms whenever needed.
The 2 procedures will be successively implemented during 3 to 4 sequences, until the number of surgical procedures statistically required have been studied.
The investigators aim to demonstrate that the centralised monitored surveillance does not put the patients at risk more often than the current surveillance procedure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual surveillance | No intervention | –surveillance performed by a qualified nurse, present in the operating room during the whole anesthesia. |
| centralised monitoring surveillance | Experimental | Other: Health care organization (anesthetic surveillance)1 anesthetic nurse is posted at a centralised monitoring station outside of the 3 operating rooms, while another one can intervene inside the 3 operating rooms whenever needed. Interphones allow communication between the monitoring station and the operating rooms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patient scheduled for ocular anterior segment surgery (cataract, glaucoma, pterygium) with local or topic anesthesia
Key exclusion criteria (1 listed)
- patient refusing to participate in the study or without health insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health care organization (anesthetic surveillance) | Other | centralised monitoring surveillance |
Primary outcome
Anesthetic potential impact on surgery conditions
Time frame: during surgical procedure
Incidence rate of at least 1 of the following events, during surgery: * blood pressure > 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes) * cardiac frequency < 45/min for at least 1 mn * SaO2 <85% for at least 1 mn * poor operating conditions (rated ≤ 7 by the surgeon, on a numeric scale from 0 to 10=excellent conditions). Assessment at the exit of operating room.
8 secondary outcomes
interventions of the back-up anesthetic nurse
Time frame: during surgical procedure
patient pre-surgical stress
Time frame: baseline
pain during surgical procedure
Time frame: within 10 minutes after surgery
patient satisfaction
Time frame: within 10 minutes after surgery
incidence rate of each of the events included in the primary outcome
Time frame: during surgical procedure
patient agitation
Time frame: within 10 minutes after surgery
operating conditions
Time frame: within 10 minutes after surgery
working conditions
Time frame: at the end of a working day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 39630143Clariot S, Moures JM, Lopes L, Gatinel D, Gabison E, Nicolaos G, Salomon L, Devys JM. Centralized monitored anesthesia care by nurse anesthetist for cataract and glaucoma surgery in a 1:3 ratio: a non-inferiority study. Minerva Anestesiol. 2025 Mar;91(3):176-183. doi: 10.23736/S0375-9393.24.18455-6. Epub 2024 Dec 4.
Related trials for Ambulatory Surgical Procedures
Not yet recruiting
Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience.
Surgery Ambulatory, ENT Surgery
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Active, not recruitingObservational study
Quality ImprOvement stUdy ouTpatient Surgery rapID movE
Postoperative Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel DEVYS, MD principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health care organization (anesthetic surveillance) in people with Ambulatory Surgical Procedures and Ocular Anterior Segment Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic potential impact on surgery conditions (time frame: during surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02037009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.